. The fact that FDA has requirements for reporting of relevant safety related data supports the NIOSH presumption that a lack of information on an endpoint indicates a lack of concern for a specific type of hazard. However, after consideration of input from the public and stakeholders, NIOSH has decided to review the toxicity and the hazards related to occupational exposure to botulinum toxins. documents in the last year, 204 This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. Accordingly, NIOSH continues to propose placing ivabradine on the List. . Risk Management for Hazardous Drugs in Healthcare Settings, https://www.federalregister.gov/d/2020-09332, MODS: Government Publishing Office metadata, https://www.cdc.gov/niosh/docs/2016-161/default.html, https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html, https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings, https://www.cdc.gov/niosh/review/peer/isi/healthsafetyrisks.html. on Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. and services, go to The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. These tools are designed to help you understand the official document Four independent peer reviewers and 55 public commenters offered input on the draft Policy and Procedures; their substantive comments are summarized below, followed by NIOSH responses. Peer review comment: NIOSH should offer an example of why a drug identified as a hazardous drug because it poses as carcinogenic hazard might not be a classified as a carcinogen pursuant to the NIOSH Chemical Carcinogen Policy. hazardous drugs. The draft Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is in the docket for this activity, is intended to assist employers in establishing their own hazardous drugs management procedures specific to their workplace. The new risk management document is available for review in the docket for this activity. You can review and change the way we collect information below. Comment: Dihydroergotamine should not be placed on the List. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. NIOSH response: In streamlining the document to make it more focused on NIOSH's procedures for identifying hazardous drugs, information on controlling the risk of hazardous drug exposure in the workplace was moved to the draft NIOSH document Managing Hazardous Drug Exposures: Information for Healthcare Settings. NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. Animal studies, where available, are also used in our evaluations. documents in the last year, 1008 Comment: Olaparib should not be placed on the List because the risk to direct occupational healthcare worker exposure is anticipated to be minimal when handling intact olaparib capsules. 6. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? NIOSH response: The reviewer has interpreted the NIOSH statement differently than what the agency intended. Genotoxicity has been noted in Chinese hamster ovary cells. This information is not part of the official Federal Register document. by the Securities and Exchange Commission The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. Accordingly, NIOSH proposes to place olaparib on the List. 05/01/2023, 858 . Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. As stated in the OMB Final Information Quality Bulletin for Peer Review (Bulletin), [p]eer reviewers shall be charged with reviewing scientific and technical matters. Comment: Triazolam should not be placed on the List. For example, three drugs were added to the 2016 List after it was initially published; they are identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 web page, https://www.cdc.gov/niosh/docs/2016-161/default.html. CN-20-058-00 Therefore, all recombinant therapeutic proteins should be excluded from the List unless science-based or product-specific circumstances dictate otherwise.. We take your privacy seriously. Comment: While NIOSH describes several Bradford Hill criteria[6] Furthermore, some drugs carry multiple American Hospital Formulary Service (AHFS) code classifications and are not solely used as antineoplastic drugs. Although such drugs are not in widespread clinical use, personnel in academic and research-oriented facilities are potentially at risk from exposure to these drugs. If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. The public comments have been organized into the following topic areas: organization of the List and impact of United States Pharmacopeia (USP) Compounding Compendium chapter <800> Hazardous DrugsHandling in Healthcare Settings; the nature of the Listexposure/hazard characterization; monoclonal antibodies; periodicity; methodology/process; criteria clarification; and editorial suggestions. If a meta-analysis or systematic review is warranted for a reevaluation, NIOSH would consider these criteria on a case-by-case basis. Learn more here. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. Therefore, NIOSH no longer proposes to place osimertinib on the List. In embryo-fetal development studies of dihydroergotamine mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses approximately 0.4-1.2 times the exposures in humans receiving the maximum recommended daily dose of 4 mg or greater. Self-Regulatory Organizations; NYSE Arca, Inc. Economic Sanctions & Foreign Assets Control, Smoking Cessation and Related Indications, Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, Authority To Order the Ready Reserve of the Armed Forces to Active Duty To Address International Drug Trafficking, Revitalizing Our Nation's Commitment to Environmental Justice for All, Centers for Disease Control and Prevention, DRAFT - Managing Hazardous Drug Exposures: Information for Healthcare Settings, DRAFT - NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. NIOSH has retitled and reorganized the List in response to comments received. Please explain. Although assessing specific controls for specific exposure situations is beyond the scope of the List, information about the use of respiratory protection in the handling of hazardous drugs is found in the draft risk management document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is available in the docket for this activity. The requestor need only provide some new information that is relevant to the issue of whether the drug does or does not meet the NIOSH definition of a hazardous drug or the decision to place a drug on a particular table in the List. The definition of a hazardous drug in the draft Procedures recognizes that the molecular properties of a drug, such as the molecular weight, may substantially limit the potential for adverse health effects. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Therefore, in accordance with the draft Procedures some monoclonal antibodies may not meet the NIOSH definition of the term hazardous drug. Because the list of drugs proposed for placement on the List has been updated based on the draft Procedures, the monoclonal antibodies bevacizumab and trastuzumab are no longer proposed for placement on the List. NIOSH response: A drug may be considered a hazardous drug but not a chemical carcinogen if, for example, a drug manufacturer includes a carcinogenicity warning in the drug's package insert but the evidence for carcinogenicity has not been reviewed by the International Agency for Research on Cancer (IARC); the National Toxicology Program (NTP), within the U.S. Department of Health and Human Services; the U.S. Environmental Protection Agency (EPA); or independently by NIOSH. Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? It is not an official legal edition of the Federal Cited studies in the package insert also demonstrate impaired fertility in rats. This clearly infers human studies only. The new list format will allow organizations more flexibility for certain drugs when implementing USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings. should verify the contents of the documents against a final, official NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. better and aid in comparing the online edition to the print edition. .. The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. The goal of the standard is to help protect health - care workers from the risks associated with handling hazardous drugs. Sargent EV and Kirk GD [1988], Establishing Airborne Exposure Control Limits in the Pharmaceutical Industry, Am Ind Hyg Assoc J 49(6):309-13; Naumann BD and Sargent EV [1997], Setting Occupational Exposure Limits for Pharmaceuticals, Occup Med 12(1):67-80; Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L [2002], The Importance of Human Data in the Establishment of Occupational Exposure Limits, Hum Ecol Risk Assess 8(4):805-822. This document has been published in the Federal Register. USP 800 only states Table 1. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. One additional drug, polatuzumab vedotin, was approved by FDA's Center for Drug Evaluation and Research in July/August 2019 and its package insert includes MSHI provided by the drug's manufacturer. Comment: The List should identify those hazardous drugs that are both cytotoxic and cytostatic as well as volatile. 2. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. informational resource until the Administrative Committee of the Federal NIOSH response: The majority of these evaluations are based on the information provided in the drug package insert; thus, NIOSH relies on the quality of science generated by a drug manufacturer, subsequently reviewed by FDA during the drug approval process, and then published in the drug package insert. Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. NIOSH also conducted a peer review, with four independent reviewers, of the draft Policy and Procedures.[2]. Fluconazole is included in the List on Table 3, but for two newer azole antifungals, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug (ketoconazole) and information does not demonstrate or support that the drug meets the NIOSH definition (itraconazole) in the FRN. NIOSH's findings about each drug are as follows: Comment: The hormonal agents in Table 1 of the 2016 List that are exclusively reproductive risks, including estrogens (estrogen agonist-antagonists such as tamoxifen and antiestrogens such as anastrozole, exemestane, and letrozole), gonadotropins (leuprolide and triptorelin), antigonadotrophins (degarelix), and progestins (megestrol) should be moved to Table 2 or 3. Access 200+ compounding-related standards, Know your exposure and download the HazRx Mobile App, USP Compounding and Hazardous Drugs Courses, Hazardous DrugsHandling in Healthcare Settings, Promoting the Quality of Medicines Plus (PQM+) Program, USP Monographs for Bulk Drug Substances and Other Ingredients, National Institute for Occupational Safety and Health (NIOSH), Revision Bulletin published to clarify the term antineoplastic for the purpose of Chapter <800>, Revision Bulletin published to confirm the official date of USP General Chapter <800>, Review their work plan and past meeting summaries, Sign up for USP Healthcare Quality & Safety Updates, The United States Pharmacopeial Convention, December 1, 2019Official date for General Chapter <800>, February 1, 2016 Publication Date of General Chapter <800>. [7] Reproductive toxicity: The package insert contains MSHI stating, Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients due to the risk of transmission of talimogene laherparepvec and herpetic infection. documents in the last year, 494 NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. include documents scheduled for later issues, at the request The size of the molecule limits dermal absorption and aerosolization. Peer review comment: NIOSH should provide a more robust description of the evaluation criteria to include that these are shared across a number of other professional organizations and panels which also endorsed these same criteria.. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress. documents in the last year, 83 Open for Comment. This repetition of headings to form internal navigation links Changes to the List structure would place all drugs that meet the NIOSH definition of a hazardous drug and contain MSHI in the package insert and/or are classified by the National Toxicology Program (NTP) as known to be a human carcinogen, or classified by the International Agency for Research on Cancer (IARC) as carcinogenic or probably carcinogenic on Table 1. Botulinum toxins do not meet the criteria for placement on the List; abotulinumtoxinA and rimabotulinumtoxinB did not have labeling changes during the search period January 2014 through December 2015, and changes to the labels for onabotulinumtoxinA and incobotulinumtoxinA do not meet the criteria for organ toxicity at low doses or teratogenicity or other developmental toxicity. NIOSH response: The List is updated any time NIOSH is aware that a drug manufacturer has added special handling information to the patient information for a specific drug. [1], Fifty-seven submissions were received in docket CDC-2018-0004 (NIOSH-233-B) from 55 commenters (one commenter sent three separate submissions to the docket). Comment: Add a new category for drugs that sublime and offer information about proper handling, including the conditions under which sublimation (transition of a solid substance to a gas) happens as well as the need to filter and exhaust the work area where such drugs are used. Comment: Monoclonal antibodies do not have a cytotoxic mechanism of action and, as such, do not pose the same level of occupational risk or toxicity as conventional antineoplastic drugs. These cookies may also be used for advertising purposes by these third parties. Public Comment Summaries and NIOSH Responses, III. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. The value for low dose should be drug-specific and a function of several factors such as normal therapeutic doses, body weight, and length of exposure. USP added clarification about the application of chapter <800> to hazardous drugs, which can be found on its FAQ page.[4]. The other 273 were screened and the information available for 44 drugs suggested one or more toxic effects; those drugs were evaluated by NIOSH and shared with peer reviewers and stakeholders. Comment. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. 05/01/2023, 244 NIOSH response: NIOSH views peer review and public comment as two distinct, often complementary, tools in ensuring both quality and transparency in influential scientific information products. 1. Peer review comment: NIOSH's discussion of an employer-performed site-based risk assessment to control the risk of exposure is confusing when placed in a document describing NIOSH's hazard identification procedures. Not refining the List to identify real risks of occupational exposure could lead to overwarning for drugs that present little or no workplace risk. The package insert also cites gefitinib as exhibiting teratogenicity. Register (ACFR) issues a regulation granting it official legal status. documents in the last year, by the Energy Department These drugs should be placed on the List because of their teratogenic and/or reproductive effects or the rationale for not proposing their placement on the List should be further explained. Facility and engineering protocols. According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. provide legal notice to the public or judicial notice to the courts. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Under the draft Procedures, NIOSH's rationale, including a description of any meta-analysis or systematic review if performed, and final determination would be described in a notice published in the Federal Register. NIOSH response: It is NIOSH practice to respond to all stakeholder and public comments and peer reviews in a Federal Register notice or in a document posted in the relevant NIOSH docket, to maintain a transparent and thorough administrative record. The manufacturer or any other stakeholder is invited to comment on the sufficiency of the explanation of the basis for adding a drug to the List. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. NIOSH appreciates that a timelier List might be helpful and is working toward that end. After considering the peer and stakeholder reviews, NIOSH determined that 20 drugs and one class of drugs exhibit toxicity that meets the NIOSH definition of a hazardous drug and proposed them for placement on the List. Document page views are updated periodically throughout the day and are cumulative counts for this document. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. These markup elements allow the user to see how the document follows the Commenters included pharmacists, professional organizations and associations, pharmaceutical manufacturers, medical centers and/or health systems, individuals who provided their names but not their affiliations, a company that provides risk assessments, a drug database, an insurance company, a medical school professor, a neurologist, and an anonymous commenter. It is scheduled to be re-reviewed for the next update to the, This oncolytic viral therapy product is outside the scope of NIOSH's definition of a hazardous drug because it is approved by FDA's Center for Biologics Evaluation and Research. [FR Doc. Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. The last paragraph of this section is particularly confusing to the reader. More than 12 billion doses of hazardous drugs are handled by US providers each year. Comment: FDA-approved drugs should be reviewed in real time or NIOSH should provide off-cycle updates to the List. .. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. The FDA requirements for tested and reported endpoints generally overlap with the NIOSH definition of a hazardous drug. NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the Application section is removed. Peer review comment: Some paragraphs in the section entitled, Evidence of Health Effects in Workers from Handling Hazardous Drugs do not belong in the scientific approach section and should be moved to be part of section B Systematic and Sequential Methodology section. 6. 1. Comment: NIOSH should clarify how close chemical analogs are identified, and whether NIOSH establishes site concordance across analogs and how evidence for and against the absence of concordance is interpreted. Table 2 would now contain drugs that meet one or more of the NIOSH hazardous drug criteria and may be developmental and/or reproductive developmental toxins but are not drugs which have MSHI or are classified as carcinogens or probable carcinogens by NTP or IARC. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services announces that the following draft documents are available for public comment: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List), including those drugs proposed for placement on the 2020 List, and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. 9. The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies. See https://www.cdc.gov/niosh/docs/2016-161/default.html for all drugs with special handling information added to the 2016 List. Accordingly, NIOSH proposes to place dihydroergotamine on the List. NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. on FederalRegister.gov Table 1. Procedures for deactivating, decontaminating and cleaning. Please provide information about your professional experience, if any, of implementing control strategies for exposures to hazardous drugs in healthcare or similar settings. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. Although there is currently some guidance in the footnotes, it may be worthwhile to consider a more detailed evaluation process of relevant studies and place it in a more prominent location in the document or possibly as an Appendix.. Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. Written comments, identified by CDC-2020-0046 and docket number NIOSH-233-C, may be submitted by any of the following methods: Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. NIOSH response: The List is about 4 years behind the introduction of new drugs when it is periodically updated because there are several steps in the review process. NIOSH response: FDA-approved drugs generally have a reasonable body of toxicity information because the manufacturers are required by FDA to provide this information to ensure patient safety when seeking approval for their drugs. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. NIOSH considered peer review and public comment received in response to the February 2018 FRN, and significantly revised the draft Policy and Procedures; that document is now called Procedures. While every effort has been made to ensure that No new information has been reported that would meet the NIOSH criteria for a hazardous drug. NIOSH consulted four independent peer reviewers, who were asked to consider the following questions: Overall, the independent peer reviewers found the draft Policy and Procedures to be clearly written and supported by the available science and the reconsideration process (now referred to as reevaluation) to be adequate. Only official editions of the NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. That said, when NIOSH becomes aware of new drugs with MSHI, NIOSH identifies such drugs on the web page for the current List to immediately alert stakeholders. Two drugs included in the 2018 FRN, inotuzumab ozogamicin and trabectedin, have MSHI and are automatically added to the 2016 List. Two reviewers had questions about the information thresholds required to evaluate drugs, and all reviewers had editorial suggestions for improving the clarity of the draft. Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 [PDF - 1 MB] Managing Hazardous Drug Exposures: Information for Healthcare Settings [PDF - 4 MB] Public Comment Period Comments will be accepted until 11:59 p.m. Drawing conclusions from a methodologically flawed paper can lead to misclassification of a drug. Please provide specific examples. Comment: Providing sufficient information to rebut a NIOSH determination to add or not add a drug to the List is difficult for healthcare organizations. NIOSH does not offer peer reviews for public comment for any scientific publications because the technical and scientific review conducted by independent peer reviewers are not NIOSH products. As discussed extensively in the notice published February 14, 2018, NIOSH identified 275 potentially hazardous drugs between January 2014 and December 2015 (83 FR 6563). In addition, having an algorithm to determine the strength of a paper will also aid in minimizing any potential inter- and intra-reviewer differences. In that case, important criteria for animal studies include strength of association; consistency between studies; relevance of the model system and routes of exposure; the duration, reversibility, and recoverability of the observed effects; and concordance of those effects with effects in humans. No labeling change has ever resulted in the removal of a drug from the List, but labeling changes that demonstrate a lack of evidence of toxicity would be dealt with in the regular List updates. electronic version on GPOs govinfo.gov. Not allowing public commenters to review peer reviews before submitting their own comments to the docket is in conflict with the principle of transparency established in the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664, Jan. 14, 2005). All information these cookies collect is aggregated and therefore anonymous. In light of these changes, NIOSH proposes a new List structure, described in the preamble to the draft List, which is available for review in the docket for this activity. Employing this same train of thought to the draft policy and procedures, it would, in my opinion, be a best practice to add the drug that has insufficient information to the List until suitable scientific evidence demonstrates that it should not be included.. NIOSH defines HDs as the following: All three draft documents are available in the docket for this activity. Relevant information about this document from Regulations.gov provides additional context. NIOSH response: While some drugs may have low bioavailability by relevant routes of exposure due to molecular weight, other factors in the characterization of the hazard are considered as well. Register, and does not replace the official print version or the official Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on the List. . The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient.
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